K211783 is an FDA 510(k) clearance for the TriMed Threaded Intramedullary Nail System. This device is classified as a Screw, Fixation, Bone (Class II - Special Controls, product code HWC).
Submitted by TriMed, Inc. (Santa Clarita, US). The FDA issued a Cleared decision on August 6, 2021, 58 days after receiving the submission on June 9, 2021.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3040.
| 510(k) Number | K211783 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 09, 2021 |
| Decision Date | August 06, 2021 |
| Days to Decision | 58 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
| Product Code | HWC - Screw, Fixation, Bone |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.3040 |